RecruitingAcute Myeloid Leukemia
Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant
Eligible age
12+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory AML. The study will evaluate safety in this subject population and also the presence of efficacy signal described by elimination of residual disease to qualify subjects for stem cell transplant.
Sponsor: Huda Salman
You may qualify if…
- ✓ 1. ≥ 12 years old at the time of informed consent
- ✓ 2. Ability to provide written informed consent and HIPAA authorization.
- ✓ 3. Diagnosis of AML that is CD4+ and must have failed standard induction/ first line treatment such as intensive induction or less intensive hypomethylation and venetoclax first line. In the specific case of azacitidine and venetoclax (aza/ven), BM biopsy for response assessment on days 21-28 of first cycle. If disease progression by increasing number of blasts is documented, subject will be eligible. If no morphologic remission (persistent BM blasts above 5%) but evidence of efficacy exists, a second cycle without interruption will be given with the goal of achieving morphologic remission and repeat BM biopsy on days 21-28 of this cycle. If residual disease or disease progression is captured, then they will be considered refractory and will qualify for this trial. This is unless the subject now qualifies for a more intensive induction therapy that they did not qualify for when aza/ven was initially chosen as first-line treatment. Given the low response rate for aza/ven in the RR-AML, CR of only 13%, this combination would not be a prerequisite to qualify for the study.
- ✓ Note: If these subjects who fail first line treatment have an FDA approved treatment options available (including targeted and non-targeted treatment) for a second line treatment, they do not qualify for the trial until they also are deemed nonresponsive to those. If an approved second line is not available, subjects will be eligible after first line failure.
- ✓ 4. Creatinine clearance of \> 60ml/min (or otherwise non clinically significant, per study investigator)
- ✓ 5. alanine aminotransferase/ aspartate aminotransferase ALT/AST \< 3 x ULN
- ✓ 6. Bilirubin \< 2 x ULN (UPPER LIMIT OF NORMAL)
- ✓ 7. No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion
You may not qualify if…
- ✕ 1. CD4 negative AML
- ✕ 2. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test prior to initiation of conditioning chemotherapy, per research sites' clinical policy.
- ✕ 3. Uncontrolled active infection necessitating systemic therapy.
- ✕ 4. Active hepatitis B hb, or hepatitis C, HC, infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results exceed the lower detection limit.
- ✕ Note the following subjects will be eligible:
- ✕ Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA for 6 months prior to enrollment are eligible.
- ✕ Subjects seropositive for HBS antibodies due to hepatitis B virus vaccine with no signs or active infection (Negative HBs Ag, HBc and HBe Ags) are eligible.
- ✕ Subjects who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA for 6 months are eligible.
Where it's recruiting
Source: ClinicalTrials.gov · NCT06197672 · last updated 2026-06-24